[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Rules and Regulations]
[Pages 43923-43927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17877]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 77

[Docket No. APHIS-2014-0027]


Approved Tests for Bovine Tuberculosis in Cervids

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

-----------------------------------------------------------------------

SUMMARY: We are amending the regulations regarding official 
tuberculosis tests for captive cervids to remove the CervidTB Stat-
Pak[supreg] as an official bovine tuberculosis test for the following 
species of captive cervids: Elk, red deer, white-tailed deer, fallow 
deer, and reindeer. We are also amending the regulations to specify 
that the Dual Path Platform (DPP)[supreg] test, which was previously a 
supplemental test to be used in conjunction with the CervidTB Stat-
Pak[supreg], is now considered a primary test, as well. We are taking 
this action because the CervidTB Stat-Pak[supreg] is no longer being 
produced, and because we have determined that the DPP[supreg] test can 
reliably be used as a primary test for bovine tuberculosis in certain 
species of captive cervids. This action is necessary on an immediate 
basis so that the regulations do not continue to authorize usage of a 
discontinued test, yet still provide regulated entities with options in 
order to meet the testing requirements for captive cervids within the 
regulations.

DATES: This interim rule is effective July 29, 2014. We will consider 
all comments that we receive on or before September 29, 2014.

ADDRESSES: You may submit comments by either of the following methods:

[[Page 43924]]

     Federal eRulemaking Portal: Go to: http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0027.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0027, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-
0027 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Owen Henderson, Senior Staff 
Cervid Tuberculosis Disease Specialist, Cervid Health Program, Sheep, 
Goat, Cervid, and Equine Health Center, Surveillance, Preparedness, and 
Response Services, VS, APHIS, 2150 Centre Avenue, Building B-3-123, 
Fort Collins, CO 80526-8117; (970) 494-7317.

SUPPLEMENTARY INFORMATION: 

Background

    Bovine tuberculosis is a contagious and infectious granulomatous 
disease caused by the bacterium Mycobacterium bovis. Although commonly 
defined as a chronic debilitating disease, bovine tuberculosis can 
occasionally assume an acute, rapidly progressive course. While any 
body tissue can be affected, lesions are most frequently observed in 
the lymph nodes, lungs, intestines, liver, spleen, pleura, and 
peritoneum. Although cattle are considered to be the true hosts of M. 
bovis, the disease has been reported in several other species of 
livestock, most notably bison and captive cervids. There have also been 
instances of infection in other domestic and nondomestic animals, as 
well as in humans.
    Through the National Cooperative State/Federal Bovine Tuberculosis 
Eradication Program, the Animal and Plant Health Inspection Service 
(APHIS) of the United States Department of Agriculture (USDA) works 
cooperatively with the Nation's livestock industry and State animal 
health agencies to eradicate bovine tuberculosis from domestic 
livestock in the United States and prevent its recurrence.
    Federal regulations implementing this program are contained in 9 
CFR part 77, ``Tuberculosis'' (referred to below as the regulations) 
and in the ``Uniform Methods and Rules--Bovine Tuberculosis 
Eradication,'' which is incorporated by reference within the 
regulations. The regulations restrict the interstate movement of 
cattle, bison, and captive cervids to prevent the spread of bovine 
tuberculosis. Subpart C of the regulations (Sec. Sec.  77.20 to 77.41, 
referred to below as the captive cervid regulations) addresses captive 
cervids.
    Currently, in the captive cervid regulations, there are several 
instances in which we require captive cervids to be tested with an 
official tuberculosis test. For example, in Sec.  77.35, in order for a 
herd of captive cervids to be recognized as accredited, all cervids in 
the herd must have tested negative to at least two consecutive official 
tuberculosis tests, conducted at 9 to 15 month intervals, with certain, 
limited exceptions.
    In Sec.  77.20 of the captive cervid regulations, prior to issuance 
of this interim rule, the definition of official tuberculosis test 
listed the following as official tests for bovine tuberculosis in 
captive cervids:
     The single cervical tuberculin (SCT) test, a primary test.
     The comparative cervical tuberculin test (CCT) test, a 
supplemental test.
     The CervidTB Stat-Pak[supreg] test, a primary test.
     The Dual Path Platform (DPP[supreg]) test, a supplemental 
test.
    We specified that the SCT and CCT tests were official tuberculosis 
tests for all species of captive cervids in a final rule published in 
the Federal Register on December 31, 1998 (63 FR 72104-72129, Docket 
No. 92-076-2). We added the CervidTB Stat-Pak[supreg] and DPP[supreg] 
tests as official tuberculosis tests for captive elk, red deer, white-
tailed deer, fallow deer, and reindeer in an interim rule \1\ published 
in the Federal Register on January 9, 2013 (78 FR 1718-1723, Docket No. 
APHIS-2012-0087).
---------------------------------------------------------------------------

    \1\ To view the interim rule, its supporting documents, or the 
comments that we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0087.
---------------------------------------------------------------------------

    We solicited comments concerning the interim rule for 60 days 
ending March 11, 2013. We received 11 comments by that date. They were 
from captive cervid producers, an organization representing captive 
cervid producers within the United States, and an organization 
representing veterinarians within the United States. All commenters 
supported the rule.
    Since the interim rule was published, however, production of the 
CervidTB Stat-Pak[supreg] has been discontinued. For this reason, in 
this interim rule, we are amending the captive cervid regulations to 
remove the CervidTB Stat-Pak[supreg] from the list of official 
tuberculosis tests.
    When we were informed that the CervidTB Stat-Pak[supreg] test would 
be discontinued, we began to evaluate the possible use of the 
DPP[supreg] test as a primary test, with the intent of determining 
whether the DPP[supreg] test could be used in lieu of the CervidTB 
Stat-Pak[supreg] test once the latter ceased to be produced. We have 
determined that it can be used in such a manner. Accordingly, this rule 
also amends the captive cervid regulations to establish a testing 
protocol in which the DPP[supreg] test is used as both a primary and 
supplemental test for bovine tuberculosis in elk, red deer, white-
tailed deer, fallow deer, and reindeer. Below, we discuss the changes 
we are making to the captive cervid regulations, by section.

Definitions (Sec.  77.20)

    As we mentioned previously, prior to issuance of this interim rule, 
the definition of official tuberculosis test in Sec.  77.20 listed the 
CervidTB StatPak[supreg] as an official tuberculosis test. We are 
amending the definition of official tuberculosis test to remove the 
CervidTB StatPak[supreg] from the official tuberculosis tests listed in 
the definition.
    Section 77.20 also provides definitions of each official 
tuberculosis test. We are removing the definition of CervidTB Stat-
Pak[supreg].
    The definition of designated accredited veterinarian in Sec.  77.20 
had stated that, among other things, a designated accredited 
veterinarian is an accredited veterinarian who is trained and approved 
to draw the blood samples needed for the CervidTB Stat-Pak[supreg] and 
DPP[supreg] test. (Both tests are serological.) We are amending the 
definition of designated accredited veterinarian to remove reference to 
the CervidTB Stat-Pak[supreg] test.

Testing Procedures for Tuberculosis in Captive Cervids (Sec.  77.33)

    Section 77.33 of the captive cervid regulations specifies, among 
other things, who may administer official tuberculosis tests, which 
diagnostic laboratories have been approved by APHIS, the reporting 
requirements for each test, and how the tests will be interpreted. We 
are removing references to the CervidTB Stat-Pak[supreg] test from this 
section. We are also updating the Web addresses provided in paragraph 
(d)(2) of the section in light of a recent redesign of APHIS' Web site, 
and replacing a reference to ``local area VS offices'' in the same 
paragraph with the

[[Page 43925]]

term ``District offices,'' which reflects current Agency terminology.

Official Tuberculosis Tests (Sec.  77.34)

    As we mentioned previously, Sec.  77.34 of the captive cervid 
regulations contains requirements regarding the sequence in which 
official tuberculosis tests should be administered and the manner in 
which test results should be interpreted for purposes of the captive 
cervid regulations. Requirements regarding primary tests for 
tuberculosis are contained in paragraph (a) of Sec.  77.34; 
requirements for supplemental tests in paragraph (b). We are amending 
paragraph (a) of Sec.  77.34 to reflect the fact that the CervidTB 
Stat-Pak[supreg] test is discontinued, and the DPP[supreg] test may now 
be used as a primary test.
    As amended, paragraph (a) of Sec.  77.34 specifies that the 
DPP[supreg] test is a primary test that may be used in individual 
captive elk, red deer, white-tailed deer, fallow deer, and reindeer, 
and in herds of these species that are of unknown tuberculous status. 
It further specifies that, with limited exceptions, each captive cervid 
that has non-negative test results to this initial DPP[supreg] test 
will be classified as a suspect and retested with the DPP[supreg] test 
no sooner than 30 days; a captive cervid that has non-negative test 
results to the DPP[supreg] test must not be retested using the SCT or 
CCT test. (We are also amending the paragraph to specify that the each 
captive cervid that responds to the SCT test must not be retested with 
the DPP[supreg] test.) Finally, it allows the DPP[supreg] test to be 
used in affected herds of captive elk, red deer, white-tailed deer, 
fallow deer, and reindeer, and in herds of these species that have 
received captive cervids from an affected herd; in such instances, each 
captive cervid that has non-negative test results to the DPP[supreg] 
test will be classified as a reactor, unless APHIS determines that the 
captive cervid should be classified as a suspect because of possible 
exposure to a tuberculous animal.
    With minor changes, these requirements for the use of the 
DPP[supreg] test as a primary test mirror the requirements that had 
previously been in paragraph (a) of Sec.  77.34 regarding use of the 
CervidTB Stat-Pak[supreg] test as a primary test. Most of the changes 
are editorial; one, which removes a reference to designated 
tuberculosis epidemiologists, reflects an organizational restructuring 
in APHIS and is discussed in greater detail later in this document.
    We are specifying that most captive cervids that have non-negative 
test results to the initial DPP[supreg] test must be classified as 
suspects and retested no sooner than 30 days later using the 
DPP[supreg] test as a supplemental test. By reduplicating the initial 
testing conditions to the extent practicable at such an interval, we 
have firm confidence in the test results provided by this second 
DPP[supreg] test.
    As amended, paragraph (b) of Sec.  77.34 specifies that the 
DPP[supreg] test may be used as a supplemental test to retest captive 
cervids that have been classified as suspects based on an initial 
DPP[supreg] test. It further specifies that this supplemental test must 
evaluate a serum sample drawn from the cervid no sooner than 30 days 
after the initial DPP[supreg] test, and that a captive cervid that has 
non-negative test results to two successive DPP[supreg] tests must be 
classified as a reactor, unless APHIS determines that another disease 
classification is warranted.

Interstate Movements (Sec.  77.39)

    Section 77.39 of the captive cervid regulations contains 
restrictions on the interstate movement of captive cervid herds 
involved in an epidemiological investigation or subject to affected 
herd management. We are removing references to and provisions regarding 
the CervidTB Stat-Pak[supreg] test from this section.

Miscellaneous

    Since the January 2013 interim rule to add the CervidTB Stat-
Pak[supreg] and DPP tests to the captive cervid regulations was issued, 
the Office of Management and Budget (OMB) has approved the paperwork 
associated with that interim rule under the control number 0579-0412. 
We are adding a reference to this approval to Sec.  77.33, which 
contains the paperwork requirements for which we sought OMB approval.
    Additionally, since the interim rule was published, APHIS' 
Veterinary Services program has undergone a reorganization. As a result 
of this reorganization, APHIS has eliminated the role of designated 
tuberculosis epidemiologist (DTE). The functions previously reserved 
for DTEs are now performed by various APHIS personnel. As a result, we 
are removing references to DTEs from the captive cervid regulations, 
and are removing the definition of designated tuberculosis 
epidemiologist from Sec.  77.2 of the regulations. We are replacing the 
references to DTEs within the captive cervid regulations with 
references to APHIS.

Immediate Action

    Immediate action is warranted to provide regulated entities who 
must have their captive cervids tested in order to comply with the 
captive cervid regulations with additional testing options following 
discontinuation of the CervidTB Stat-Pak[supreg] test. Under these 
circumstances, the Administrator has determined that prior notice and 
opportunity for public comment are contrary to the public interest and 
that there is good cause under 5 U.S.C. 553 for making this rule 
effective less than 30 days after publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register in which we 
will respond to the comments we receive and finalize or, as necessary, 
revise the provisions of this interim rule.

Executive Order 12866 and Regulatory Flexibility Act

    This interim rule is subject to Executive Order 12866. However, for 
this action, the Office of Management and Budget has waived its review 
under Executive Order 12866.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities.
    This rule removes the CervidTB Stat-Pak[supreg] as an official 
tuberculosis test for captive cervids, and establishes a testing 
protocol where the DPP[supreg] test may be used in lieu of the CervidTB 
Stat-Pak[supreg] test.
    It is APHIS policy that owners are responsible for assuming the 
costs associated with primary official tuberculosis tests for bovine 
tuberculosis in captive cervids; the Agency assumes the cost of 
corroboratory testing. Bovine tuberculosis testing using the SCT test, 
including veterinary fees, costs about $10 to $15 per head. We have 
estimated bovine tuberculosis testing using the DPP[supreg] test to 
cost approximately $13 to $15 per head. Owners of captive cervids will 
not be required to use the DPP[supreg] test instead of the SCT test, 
but may choose to do so if they determine such use to be cost-effective 
for their operations.
    That being said, we do anticipate that producers may, in certain 
instances, experience benefits because of the availability of the 
DPP[supreg] test as official primary tuberculosis test for captive 
cervids. This is because of the nature of the DPP[supreg] test. As a 
serological test, it is relatively easy to administer, in comparison to 
the SCT and CCT tests, and does not require the animals to be held for 
a significant period of time while the test is applied. There is thus a 
lower risk of misapplication of the

[[Page 43926]]

tests and morbidity due to handling of the animals during application.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. It has no preemptive effect.

Paperwork Reduction Act

    This rule contains no new information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

List of Subjects in 9 CFR Part 77

    Animal diseases, Bison, Cattle, Reporting and recordkeeping 
requirements, Transportation, Tuberculosis.

    Accordingly, we are amending 9 CFR part 77 as follows:

PART 77--TUBERCULOSIS

0
1. The authority citation for part 77 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


Sec.  77.2  [Amended]

0
2. Section 77.2 is amended by removing the definition of designated 
tuberculosis epidemiologist (DTE).

0
3. Section 77.20 is amended as follows:
0
a. In the definition of designated accredited veterinarian, by removing 
the words ``CervidTB Stat-Pak[supreg] test and'';
0
b. By revising the definition of official tuberculosis test; and
0
c. By removing the definition of CervidTB Stat-Pak[supreg] test.
    The revision reads as follows:


Sec.  77.20  Definitions.

* * * * *
    Official tuberculosis test. Any of the following tests for bovine 
tuberculosis in captive cervids, applied and reported in accordance 
with this part:
    (1) The single cervical tuberculin (SCT) test.
    (2) The comparative cervical tuberculin test (CCT) test.
    (3) The Dual Path Platform (DPP[supreg]) test.
* * * * *

0
4. Section 77.33 is amended as follows:
0
a. In paragraph (a)(2), by removing the words ``CervidTB Stat-
Pak[supreg] or'';
0
b. By revising paragraphs (d)(2) and (e)(3);
0
c. By removing paragraph (e)(4); and
0
d. By adding an OMB citation at the end of the section.
    The addition and revisions read as follows:


Sec.  77.33  Testing procedures for tuberculosis in captive cervids.

* * * * *
    (d) * * *
    (2) DPP[supreg] test. The veterinarian who draws blood from the 
captive cervid must submit a form specified by APHIS for such requests 
to NVSL to perform the DPP[supreg] test on the blood sample. The form 
is available at the following Web site: http://www.aphis.usda.gov/wps/portal/footer/resources/forms; click on the ``VS forms'' link on that 
Web page. The veterinarian must also fill out the relevant portions of 
a test record. This form may be obtained by contacting the local 
district VS office, information regarding which is available at: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalhealth?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_our_focus%2Fsa_animal_health%2Fsa_contact_us%2Fsa_map%2Fct_state_contacts_map. This record must be sent to the offices of the 
State and Federal animal health officials in the State.
    (e) * * *
    (3) Interpretation of DPP[supreg] test results will be in 
accordance with the classification requirements described in Sec.  
77.34.
* * * * *

(Approved by the Office of Management and Budget under control number 
0579-0412)

0
5. Section 77.34 is amended as follows:
0
a. In paragraphs (a)(1) and (b)(1), by removing the words ``the DTE'' 
each time that they occur, and adding the word ``APHIS'' in their 
place;
0
b. In paragraph (a)(1), by removing the words ``CervidTB Stat-
Pak[supreg] or DPP[supreg] tests'' and adding the words ``DPP[supreg] 
test'' in their place; and
0
c. By revising paragraphs (a)(2) and (b)(2).
    The revisions read as follows:


Sec.  77.34  Official tuberculosis tests.

    (a) * * *
    (2) DPP[supreg] test. (i) The DPP[supreg] test is a primary test 
that may be used in individual captive elk, red deer, white-tailed 
deer, fallow deer, and reindeer, and in herds of these species that are 
of unknown tuberculous status. Except as specified in paragraph 
(a)(2)(ii) of this section, each captive cervid that has non-negative 
test results to this initial DPP[supreg] test will be classified as a 
suspect and retested with the DPP[supreg] test. A captive cervid that 
has non-negative test results to the DPP[supreg] test must not be 
retested using the SCT or CCT test.
    (ii) The DPP[supreg] test is a primary test that may be used in 
affected herds of captive elk, red deer, white-tailed deer, fallow 
deer, and reindeer, and in herds of these species that have received 
captive cervids from an affected herd. In such herds, each captive 
cervid that has non-negative test results to the DPP[supreg] test will 
be classified as a reactor, unless APHIS determines that the captive 
cervid should be classified as a suspect because of possible exposure 
to a tuberculous animal.
    (b) * * *
    (2) DPP[supreg] test. The DPP[supreg] test may be used as a 
supplemental test in order to retest captive cervids that have been 
classified as suspects based on an initial DPP[supreg] test. In such 
instances, the supplemental DPP[supreg] test must evaluate a new serum 
sample drawn from the cervid no sooner than 30 days after the initial 
DPP[supreg] test. A captive cervid that has non-negative test results 
on two successive DPP[supreg] tests will be classified as a reactor, 
unless APHIS determines that another disease classification is 
warranted.


Sec.  77.39  [Amended]

0
6. Section 77.39 is amended as follows:
0
a. By removing paragraph (a)(1)(iii);
0
b. By redesignating paragraph (a)(1)(iv) as paragraph (a)(1)(iii);
0
c. In paragraphs (b)(2)(iv) and (c), by removing the words ``the DTE'' 
and adding the word ``APHIS'' in their place;
0
d. In paragraph (e), introductory text, by removing the words 
``CervidTB Stat-Pak[supreg]'' each time they appear and adding the word 
``DPP[supreg]'' in their place;
0
e. In paragraph (e)(2), by removing the words ``the DTE'' and adding 
the word ``APHIS'' in their place;
0
f. In paragraph (e)(3), by removing the words ``CervidTB Stat-
Pak[supreg]'' each time they appear and adding the word ``DPP[supreg]'' 
in their place;
0
g. In paragraph (f)(1), by removing the words ``CervidTB Stat-
Pak[supreg]'' each time they appear and adding the word ``DPP[supreg]'' 
in their place and by removing the words ``the DTE'' and adding the 
word ``APHIS'' in their place; and

[[Page 43927]]

0
h. In paragraph (f)(2), by removing the words ``CervidTB Stat-
Pak[supreg]'' and adding the word ``DPP[supreg]'' in their place.

    Done in Washington, DC, this 23rd day of July 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-17877 Filed 7-28-14; 8:45 am]
BILLING CODE 3410-34-P